This position offers the flexibility to work from home.
We have an excellent new opportunity for an individual with a background and expertise working either within the medical communications, clinical trials, or regulatory fields, to join our medical writing team at a senior level (Lead Medical Writer).
This position would suit an experienced CRA (Clinical Research Associate) who could offer their clinical expertise with their understanding of clinical trials and regulations around protocols and who understands patients’ needs.
The Lead Medical Writer will oversee development of Sponsor communication programmes (in patient recruitment or retention), demonstrating in-depth knowledge and understanding of relevant scientific and clinical data for the product and will have the ability to rapidly get up to speed. They will also act as medical writing lead on complex client programmes, co-ordinating medical writing resources, as required; have the ability to think strategically and act as medical lead providing strategic insights to shape projects and proposals; have a keen attention to detail and be able to critically appraise and QC work from other writers for accuracy and relevance; work across a number of multi-functional teams from across the Scientific Affairs and Medical Writing (SAMW) team, Site & Patient Networks and other QuintilesIMS’ Divisions.
Importantly, they will act as senior reviewer for informed consent forms (ICFs) and will be a vital part of the internal QC for ICFs.
- Review written materials produced by team members on assigned accounts, coaching and mentoring staff, as appropriate. Ensure communication materials are delivered to a high quality, on time and within budget keeping relevant parties aware of the status of project activities.
- Proactively contribute creative ideas, concepts or suggestions to provide added value on assigned accounts and create business growth opportunities
- Advise and consult with internal and external stakeholders on areas of expertise. Lead meetings with relevant stakeholders, presenting scientific/clinical concepts and facilitating discussions as required. Cultivate strong, long-term working relationships with internal and external key decision-makers
- In conjunction with other senior medical team members forward-plan resource for the department, supervising staff and freelancers on assigned accounts, as appropriate
- Help to develop project specifications and cost estimates on assigned accounts, working closely with account teams
We try to involve our staff in as wide a variety of outputs as possible - no-one is limited to writing on one therapy area for one target audience. Equally, wherever possible, we empower our staff to develop a particular expertise if that is what interests them.
QuintilesIMS offers a competitive salary and great benefits, including a profit-related annual bonus, private health insurance and a generous company pension scheme.
Required Skills & Experience
A PhD and/or relevant bachelor’s degree in a scientific or medical field
Demonstrable knowledge/understanding of drug development and clinical trials
Proven experience in writing in the medical/scientific and/or clinical communications field, to at least Senior Medical Writer level
Some experience writing for patients and/or on clinical projects - preferred
First-hand experience of clinical trials communications and informed consent forms – preferred
Excellent attention to detail
Concise and logical writing style
Ability to adapt writing style to meet the needs of different audiences (from lay to clinical)
Ability to write to a brief and meet the required specifications and objectives, and follow industry guidelines and style guides
Ability to perform multiple tasks and prioritise work effectively
Adaptable and able to concentrate and maintain focus under time pressure
Ability to establish and maintain effective working relationships with co-workers, managers, and clients
Ability to critically appraise the work of other writers, for scientific accuracy, appropriateness of content, flow and adherence/compliance with regulations
Proven ability to coach/mentor team members
Quick learner and self-starter
Good awareness of current industry code of practice guidelines and their implications
Strong presentation skills